NCT01374620

Weekly Paclitaxel and Cyclophosphamide in Metronomic Administration : Dose Escalation Study of Weekly Paclitaxel

Phase I Study : Dose Escalation of Intravenous Weekly Paclitaxel in Association With Metronomic Administration of Cyclophosphamide

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Centre Oscar Lambret · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to determine the MTD of Paclitaxel in association with metronomic Cyclophosphamide.

Detailed description

The aim of the study is to determine the MTD of Paclitaxel in association with metronomic Cyclophosphamide for cancer which present no therapeutic solution

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel dose escalation	Paclitaxel will be administered intravenously over 60 minutes, at D1, D8 and D15, at a given dose. The Paclitaxel dose (mg/infusion) levels are as follows: * 40 * 60 * 70 * 75 * 80 * 85 * 90
DRUG	Paclitaxel	Patients will be treated at the recommended dose in order to confirm the recommended paclitaxel dose in association with metronomic cyclophosphamide
DRUG	Cyclophosphamide	D1 to D28: 50 mg x 2/day/cycle 1 cycle = 28 days
BIOLOGICAL	Blood collection	At D1, D8, D15 and D21 of cycle 1 and cycle 2:2 blood samples for the correlation between clinical response and biological parameters

Timeline

• Start date: 2011-07-13
• Primary completion: 2013-02-01
• Completion: 2013-04-01
• First posted: 2011-06-16
• Last updated: 2026-03-16

Locations

1 site across 1 country: France